SAO PAULO Brazil’s Parana state is in talks to produce a COVID-19 vaccine approved by Russia despite not having completed mass clinical trials, but it was unclear if the state’s research institute would get regulatory approval in Brazil.
Tuesday’s announcement by the Parana Technology Institute (Tecpar) took Brazil’s regulators and health experts by surprise, with some raising doubts about the institute’s capacity to produce large volumes of a new vaccine from scratch.
Tecpar’s spokesman João Pedro Schonarth told Reuters talks were underway, and the state government said Governor Ratinho Júnior was set to meet the Russian ambassador to Brazil on Wednesday.
The spokesperson for the southern state declined to say if a production deal would be signed at the meeting.
With the world’s biggest coronavirus outbreak outside the United States, Brazil has become a hub for mass clinical trials of potential vaccines.
Brazilian officials have vowed to start making vaccines developed by British and Chinese researchers within a year, but experts warn it may take at least twice as long.
Moscow’s decision to grant approval for its vaccine before completing clinical trials has raised concerns among some experts. About 10% of clinical trials are successful.
Moscow on Tuesday hailed its breakthrough, after less than two months of human testing, as evidence of Russia’s scientific prowess.
Russian business conglomerate Sistema has said it expects mass production by the end of the year.
Any production arrangement in Brazil would require approval by health regulator Anvisa. The agency said it had not yet received a request to authorize the Russian vaccine and that it could not comment on its safety or effectiveness before receiving data from the laboratory responsible for development.
Two former senior Anvisa officials told Reuters they did not believe Tecpar had the capability to mass produce the vaccine. One of them, a former head of the regulator, said Tecpar now produces only one vaccine – to protect animals against rabies. Both sources requested anonymity to speak frankly.
The Parana state government dismissed the concerns, telling Reuters in an email that Tecpar has the “technical capacity to participate in the process.”
Brazil has registered more than 3 million cases of the novel coronavirus as President Jair Bolsonaro urges a reopening of the economy. The official death toll passed 100,000 this weekend.
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